Ruben Lopez Resillas
Engineer
Portland,ME
Summary
Detail-oriented Manufacturing Engineer with 5+ years of experience. Proficient in medical device grade process and equipment validation. Strong understanding of manufacturing processes and automated vision systems for both implantable and non-implantable medical devices.
Overview
5
5
years of post-secondary education
5
5
years of professional experience
Work History
Validation Lead
Abbott Diagnostics
Westbrook, ME
06.2020 - Current
- Trained and developed 4 direct reports to write and execute validations within 2 months including data capability analysis, DOE, and gage R&R.
- Led team of 5 manufacturing engineers to validate 60 manufacturing lines. Streamlined timeline 30% by characterizing process using DOE and process capability analysis.
- Designed and executed site validation documentation strategy required to bring 10 automated assembly and packaging manufacturing lines. Collaborated with across-functional team in order to create URS, SOW, and FAT for automated capital equipment.
- Developed and implemented process flow improvement and standardization projects
Manufacturing Engineer
Abbott Neuromodulation Division
Plano, TX
08.2017 - 10.2020
- Responsible over DRG leads & extensions, DBS leads & extensions, sterile packaging, and final packaging manufacturing lines.
- Project manager to replace $230M of laser engravers, sealers, packaging testing equipment. Developed RCE and roadmap for validation.
- Optimized battery shelf life of external programmers to improve scrap/yield and maintain 98% average.
- Experience utilizing process capability data and SPC to control and improve processes. Collaborated using Six Sigma principles to decrease laser weld defects for leads and increase yield by 30%.
Manufacturing Engineering Co-op
St. Jude Medical
Plano, TX
06.2016 - 05.2017
- Led Board Assembly Process Change for IPG non-rechargeable line saving approx. $300,000+/year. Developed fixtures with electrical interface to reset units in POR state & implemented AOI system.
- Developed and designed Twist reflow fixture for DBS manufacturing line. Programmed and implemented multi-stepper motor to improve process reliability.
Education
Certificate - Project Management Certificate
University Of South Carolina - Columbia
Columbia, SC 11.2019 - 11.2019
Bachelor of Science - Mechanical Engineering
University of North Texas
Denton, TX 06.2012 - 08.2017
Skills
21 CFR 820 and ISO 13485 regulations
Timeline
Validation Lead
Abbott Diagnostics
06.2020 - Current
Certificate - Project Management Certificate
University Of South Carolina - Columbia
11.2019 - 11.2019
Manufacturing Engineer
Abbott Neuromodulation Division
08.2017 - 10.2020
Manufacturing Engineering Co-op
St. Jude Medical
06.2016 - 05.2017
Bachelor of Science - Mechanical Engineering
University of North Texas
06.2012 - 08.2017
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